Ascension MCP
FDA premarket approval P000057/S010 · decided 2018-06-29
Approval details
- PMA number
- P000057
- Supplement
- S010
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Ascension MCP
- Generic name
- Finger semi-constrained pyrolytic carbon uncemented prosthesis
- Applicant
- Smith & Nephew, Inc.
- Date received
- 2017-10-03
- Decision date
- 2018-06-29
- Days to decision
- 269 days
- Decision code
- APPR
- Product code
- NEG
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Cordova, TN
- Statement
- Approval for a manufacturing site located at Integra Life Sciences Corporation (Integra), 11101 Metric Boulevard, Austin, Texas.
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